Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00588900
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving irinotecan together with cediranib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving irinotecan together with cediranib works in treating patients with metastatic colorectal cancer that did not respond to previous oxaliplatin, fluoropyrimidine, and bevacizumab.

Key Dates

Start date
Mar 31, 2008
Status verified
Mar 2017
Primary completion
May 31, 2010
Completion
Nov 30, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan + cediranib
    Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral cediranib once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for up to 2 years from study entry.

Primary Outcome Measure

The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy [ Time Frame: at 12 weeks ]

Locations (31)

FacilityCityStateZIPSite coordinators
Evanston HospitalEvanstonIllinois60201-1781-
Elkhart Clinic, LLCElkhartIndiana46514-2098-
Elkhart General HospitalElkhartIndiana46515-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46845-
Howard Community HospitalKokomoIndiana46904-
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa PorteIndiana46350-
CCOP - Northern Indiana CR ConsortiumSouth BendIndiana46601-
Memorial Hospital of South BendSouth BendIndiana46601-
Michiana Hematology-Oncology, PC - South BendSouth BendIndiana46601-
Saint Joseph Regional Medical CenterSouth BendIndiana46617-
South Bend ClinicSouth BendIndiana46617-
Hematology Oncology Associates of the Quad CitiesBettendorfIowa52722-
Holden Comprehensive Cancer Center at University of IowaIowa CityIowa52242-1002-
Lakeland Regional Cancer Care Center - St. JosephSaint JosephMichigan49085-
Lakeside Cancer Specialists, PLLCSaint JosephMichigan49085-
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbiaMissouri65203-
Cancer Resource Center - LincolnLincolnNebraska68510-
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmahaNebraska68124-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106-
Creighton University Medical CenterOmahaNebraska68131-2197-
Immanuel Medical CenterOmahaNebraska68122-
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcordNew Hampshire03301-
New Hampshire Oncology - Hematology, PA - HooksettHooksettNew Hampshire03106-
Lakes Region General HospitalLaconiaNew Hampshire03246-
CCOP - Hematology-Oncology Associates of Central New YorkEast SyracuseNew York13057-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-
Wayne Memorial Hospital, IncorporatedGoldsboroNorth Carolina27534-
Kinston Medical SpecialistsKinstonNorth Carolina28501-
Rex Cancer Center at Rex HospitalRaleighNorth Carolina27607-
Iredell Memorial HospitalStatesvilleNorth Carolina28677-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

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